丹红注射液对冠心病经皮冠状动脉介入术后内皮功能影响的系统评价
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摘要
目的:系统评价丹红注射液对冠心病经皮冠状动脉介入术后的内皮功能的影响,为进一步研究设计提供依据。方法:计算机检索CNKI、VlP、Wanfang Data、CBM、PubMed、The Cochrane Library、EMbase等7个数据库,查找关于丹红注射液联合常规用药对冠心病经皮冠状动脉介入后内皮功能影响的随机对照试验(RCT)。由2位评价员独立筛选文献、提取资料并评价纳入研究的偏倚风险后,采用RevMan 5.3软件进行数据统计分析。结果:共纳入12个RCT,涉及1325名患者。经Meta分析发现治疗组(丹红注射液联合常规治疗)在改善术后各内皮指标方面均优于对照组(常规治疗),具体为指标NO[MD=9.57,95%CI(8.22,10.93),P <0.00001]、指标vWF[MD=-31.60,95%CI(-41.47,-21.72),P <0.00001]、指标ET[SMD=-0.92,95%CI(-1.49,-0.35), P <0.01]、指标ET-1[SMD=C-2.19,95%CI(-3.11,-1.27),P <0.00001]、指标FMD[MD=1.81,95%CI(1.26,2.37),P <0.00001],各个指标间均有统计学意义。结论:丹红注射液联合常规治疗与常规治疗相比,更能改善冠心病PCI术后的内皮功能。但由于纳入文献质量较低,且存在异质性较大问题,上述结论仍需通过高质量多中心、大样本、双盲随机对照试验来进一步验证。
Objective: To evaluate the effect of Danhong injection on endothelial function after percutaneous coronaryintervention(PCI) in coronary heart disease(CHD). It provides the basis for further research and design. Methods: Sevendatabases of CNKI, VIP, Wanfang Data, CBM, PubMed, The Cochrane Library, Embase and others were searched bycomputer cents with coronary heart disease treated by Danhong injection combined with conventional drugs. Twoevaluators independently sifted the literature, extracted the data and evaluated the bias risk in the study. The data werestatistically analyzed by RevMan 5.3 software. Results: A total of 12 RCTs, involving 1325 patients were included. Metaanalysis showed that the treatment group(Danhong injection combined with routine therapy) was superior to the controlgroup in improving the endothelium index after operation. The index NO[MD=9.57,95%CI(8.22,10.93), P < 0.00001],vWF [MD=-31.60,95%CI(-41.47,-21.72), P < 0.00001], ET-1 [MD=-2.19, 95%CI(-3.11,-1.27), P < 0.00001], ET[SMD=-0.92, 95%CI(-1.49,-0.35), P < 0.01], FMD[MD = 1.81, 95%CI(1.26, 2.37), P < 0.00001]. There was statisticalsignificance between each index. Conclusion: Danhong injection combined with conventional therapy can improveendothelial function after PCI. However, due to the low quality of included studies and the problem of heterogeneity,these conclusions need to be further verified by high quality multicenter, large sample and double blind randomizedcontrolled trials.
Objective: To evaluate the effect of Danhong injection on endothelial function after percutaneous coronaryintervention(PCI) in coronary heart disease(CHD). It provides the basis for further research and design. Methods: Sevendatabases of CNKI, VIP, Wanfang Data, CBM, PubMed, The Cochrane Library, Embase and others were searched bycomputer cents with coronary heart disease treated by Danhong injection combined with conventional drugs. Twoevaluators independently sifted the literature, extracted the data and evaluated the bias risk in the study. The data werestatistically analyzed by RevMan 5.3 software. Results: A total of 12 RCTs, involving 1325 patients were included. Metaanalysis showed that the treatment group(Danhong injection combined with routine therapy) was superior to the controlgroup in improving the endothelium index after operation. The index NO[MD=9.57,95%CI(8.22,10.93), P < 0.00001],vWF [MD=-31.60,95%CI(-41.47,-21.72), P < 0.00001], ET-1 [MD=-2.19, 95%CI(-3.11,-1.27), P < 0.00001], ET[SMD=-0.92, 95%CI(-1.49,-0.35), P < 0.01], FMD[MD = 1.81, 95%CI(1.26, 2.37), P < 0.00001]. There was statisticalsignificance between each index. Conclusion: Danhong injection combined with conventional therapy can improveendothelial function after PCI. However, due to the low quality of included studies and the problem of heterogeneity,these conclusions need to be further verified by high quality multicenter, large sample and double blind randomizedcontrolled trials.
引文
1冠心病合理用药指南(第2版).中国医学前沿杂志(电子版),2018,10(6):1-130.
2 Kelly B B,Narula J,Fuster V.Recognizing global burden of cardiovascular disease and related chronic diseases.Mt Sinai J Med,2012,79(6):632.
3国家心血管病中心.中国心血管病报告2015.北京:中国大百科全书,2016.
4中华医学会心血管病学分会介入心脏病学组.中国医师协会心血管内科医师分会.血栓防治专业委员会.中国经皮冠状动脉介入治疗指南.中华心血管病杂志,2016(44):382-400.
5刘红旭,吴永健,王显,等.经皮冠状动脉介入治疗围手术期心肌损伤中医诊疗专家共识.中国中西医结合杂志,2017,37(4):389-393.
6 Yoshiaki M,Takafumi U,Shinji,et al.Coronary Endothelial Dysfunction Distal to Stent of First-Generation Drug-Eluting Stents.JACC:Cardiovascular Interventions,2012(9):1-10.
7王硕,何俗非,翟静波,等.丹红注射液药理作用及临床应用研究进展.中国中医药信息杂志,2014,21(3):128-131.
8颜红兵.临床冠心病诊断与治疗指南.北京:人民卫生出版社,2010:17-55.
9中华医学会心血管病学分会,中华心血管病杂志编辑委员会,《中国循环杂志》编辑委员会.急性心肌梗死诊断和治疗指南.中华心血管病杂志,2001,29(12):710-725.
10中华医学会心血管病学分会,中华心血管病杂志编辑委员会.冠心病诊断与治疗指南.中华心血管病杂志,2007,35(3):195-206.
11世界卫生组织.ACS诊断标准.1981.
12中华医学会心血管病学分会.不稳定型心绞痛的诊断和治疗.中华心血管病杂志,2000,28(6):402-409.
13 Antman E M,Hand M,Armstrong P W,Bates E R,et al.2007 focused update of the ACC/AHA 2004 guidelines for the management of patients with STelevation myocardial infarction:A report of the American College of Cardiology/American Heart Association Task Force on practice guidelines.Circulation,2008,117(2):261-295.
14 Higgins J P T,Green S.Cochrane handbook for systematic reviews of interventions version 5.1.0[updated March 2011].The Cochrane Collaboration,2011.Available at:http://handbook.cochr-ane.org.
15张涛.丹红注射液对冠心病介入治疗后血瘀证患者不良心血管事件的影响.中国实验方剂学杂志,2018,24(2):186-191.
16张薇薇,董宏伟,张文泉.丹红注射液对老年急性冠脉综合征冠状动脉介入术后血管内皮功能及炎性因子水平的影响.中国老年学杂志,2016,36(22):5591-5593.
17刘志强.急诊PCI联合丹红注射液治疗ST段抬高型急性心肌梗死疗效观察.陕西中医,2017,38(7):869-870.
18许新民等.丹红注射液对急性心肌梗死直接经皮冠状动脉介入术后缺血心肌的保护作用.东南国防医药,2015,17(5):451-454.
19郭建峰等.丹红注射液对ACS患者PCI术后血管内皮功能及炎性因子水平的影响.中国实验方剂学杂志,2015,21(12):154-157.
20董春桃,杜丽华.丹红注射液对不稳定型心绞痛患者冠状动脉介入术后血管内皮的保护作用.中国基层医药,2015,22(22):3407-3409.
21张永香,张强.丹红注射液对急性冠脉综合征患者介入治疗后的心肌保护作用.中国实验方剂学杂志,2012,18(23):308-311.
22肖勇,曹登瑞.丹红对急性冠脉综合征患者介入治疗术后血管内皮功能的影响.西部医学,2010,22(7):1214-1215+1218.
23 Zhao S.Treatment of Danhong Injection Combined withNaoxintong Capsule in Acute Coronary Syndrome Patients Undergoing PCI Operation:Study for a Randomized Controlled and Double-Blind Trial.EvidenceBased Complementary and Alternative Medicine,2018(8):8485472.
24 Liang H.Danhong injection effects on vascular endotheliaI function in patients undergoing coronary artery stent implantation.Journal of Clinical Rehabilitative Tissue Engineering Research,2010,14(13):2467-2470.
25杨靖等.丹红注射液治疗ST段抬高型心肌梗死直接经皮冠状动脉介入术后无复流/慢血流的研究.世界中西医结合杂志,2015,10(2):210-213+225.
26叶世权,马东明,杨军.丹红注射液联合氯吡格雷对急性冠脉综合征患者经皮冠状动脉介入治疗术后血清内皮素1、一氧化氮水平的影响.实用心脑肺血管病杂志,2017,25(6):148-150.
27 Zhen Hu,Hong Wang,Guanwei Fan et al.Effect of danhong injection on the mobilisation of endo thelial progenitor cells to vascular repair after percutaneous coronary intervention:a randomized controlled trial.Lancet,2016,388:S34-S34.
28 Hamasaki S C,Tei C W.Effect of coronary endothelial function on outcomes in patients undergoing percutaneous coronary intervention.Journal of Cardiology,2011,57(3):231-238.
29杨丽峰,吕吉元,贾永平.经皮冠状动脉介入治疗对急性冠状动脉综合征患者内皮功能的影响.中国动脉硬化杂志,2005,13(4):93-94.
30顼志兵,汪卫东,张莉芬,等.冠心病中医证型与血浆vWF,Ps,hsCRP,FIB,TXB2,6-keto-PG1α关系的临床研究.中国中医基础医学杂志,2015,21(1):66-68.
31 Yan Bgi Bwa M,Kurihar H,Kimura S,et al.A novelpotent Vasoconstrictor peptide produced by vascular endothelial cells.Nature,1988,332:411-415.
32张琼,宋旭东,陈爱华,唐晓明.颈、股动脉内-中膜厚度及血管内皮舒张功能与冠心病的相关性.实用医学杂志,2009,25(7):1066-1068.
33邓远琼,张志娟,李宏翔,等.血管内皮功能及同型半胱氨酸对冠心病的预测价值研究.中国全科医学,2013,16(31):3672-3675.
34王静,吴时达.中药对血管内皮功能的保护作用.中国动脉硬化杂志,2005,13(1):116-118.
35周惠芬,何昱,张宇燕,等.丹红有效成分配伍对缺氧损伤脑微血管内皮细胞的保护作用.中国中药杂志,2014,39(22):4399-4404.
36王淑君,王万铁,熊建华,等.红花注射液对脑缺血再灌注损伤家兔血浆TXA2/PGI2水平的影响.中国现代应用药学,2003,20(2):100-102.
2 Kelly B B,Narula J,Fuster V.Recognizing global burden of cardiovascular disease and related chronic diseases.Mt Sinai J Med,2012,79(6):632.
3国家心血管病中心.中国心血管病报告2015.北京:中国大百科全书,2016.
4中华医学会心血管病学分会介入心脏病学组.中国医师协会心血管内科医师分会.血栓防治专业委员会.中国经皮冠状动脉介入治疗指南.中华心血管病杂志,2016(44):382-400.
5刘红旭,吴永健,王显,等.经皮冠状动脉介入治疗围手术期心肌损伤中医诊疗专家共识.中国中西医结合杂志,2017,37(4):389-393.
6 Yoshiaki M,Takafumi U,Shinji,et al.Coronary Endothelial Dysfunction Distal to Stent of First-Generation Drug-Eluting Stents.JACC:Cardiovascular Interventions,2012(9):1-10.
7王硕,何俗非,翟静波,等.丹红注射液药理作用及临床应用研究进展.中国中医药信息杂志,2014,21(3):128-131.
8颜红兵.临床冠心病诊断与治疗指南.北京:人民卫生出版社,2010:17-55.
9中华医学会心血管病学分会,中华心血管病杂志编辑委员会,《中国循环杂志》编辑委员会.急性心肌梗死诊断和治疗指南.中华心血管病杂志,2001,29(12):710-725.
10中华医学会心血管病学分会,中华心血管病杂志编辑委员会.冠心病诊断与治疗指南.中华心血管病杂志,2007,35(3):195-206.
11世界卫生组织.ACS诊断标准.1981.
12中华医学会心血管病学分会.不稳定型心绞痛的诊断和治疗.中华心血管病杂志,2000,28(6):402-409.
13 Antman E M,Hand M,Armstrong P W,Bates E R,et al.2007 focused update of the ACC/AHA 2004 guidelines for the management of patients with STelevation myocardial infarction:A report of the American College of Cardiology/American Heart Association Task Force on practice guidelines.Circulation,2008,117(2):261-295.
14 Higgins J P T,Green S.Cochrane handbook for systematic reviews of interventions version 5.1.0[updated March 2011].The Cochrane Collaboration,2011.Available at:http://handbook.cochr-ane.org.
15张涛.丹红注射液对冠心病介入治疗后血瘀证患者不良心血管事件的影响.中国实验方剂学杂志,2018,24(2):186-191.
16张薇薇,董宏伟,张文泉.丹红注射液对老年急性冠脉综合征冠状动脉介入术后血管内皮功能及炎性因子水平的影响.中国老年学杂志,2016,36(22):5591-5593.
17刘志强.急诊PCI联合丹红注射液治疗ST段抬高型急性心肌梗死疗效观察.陕西中医,2017,38(7):869-870.
18许新民等.丹红注射液对急性心肌梗死直接经皮冠状动脉介入术后缺血心肌的保护作用.东南国防医药,2015,17(5):451-454.
19郭建峰等.丹红注射液对ACS患者PCI术后血管内皮功能及炎性因子水平的影响.中国实验方剂学杂志,2015,21(12):154-157.
20董春桃,杜丽华.丹红注射液对不稳定型心绞痛患者冠状动脉介入术后血管内皮的保护作用.中国基层医药,2015,22(22):3407-3409.
21张永香,张强.丹红注射液对急性冠脉综合征患者介入治疗后的心肌保护作用.中国实验方剂学杂志,2012,18(23):308-311.
22肖勇,曹登瑞.丹红对急性冠脉综合征患者介入治疗术后血管内皮功能的影响.西部医学,2010,22(7):1214-1215+1218.
23 Zhao S.Treatment of Danhong Injection Combined withNaoxintong Capsule in Acute Coronary Syndrome Patients Undergoing PCI Operation:Study for a Randomized Controlled and Double-Blind Trial.EvidenceBased Complementary and Alternative Medicine,2018(8):8485472.
24 Liang H.Danhong injection effects on vascular endotheliaI function in patients undergoing coronary artery stent implantation.Journal of Clinical Rehabilitative Tissue Engineering Research,2010,14(13):2467-2470.
25杨靖等.丹红注射液治疗ST段抬高型心肌梗死直接经皮冠状动脉介入术后无复流/慢血流的研究.世界中西医结合杂志,2015,10(2):210-213+225.
26叶世权,马东明,杨军.丹红注射液联合氯吡格雷对急性冠脉综合征患者经皮冠状动脉介入治疗术后血清内皮素1、一氧化氮水平的影响.实用心脑肺血管病杂志,2017,25(6):148-150.
27 Zhen Hu,Hong Wang,Guanwei Fan et al.Effect of danhong injection on the mobilisation of endo thelial progenitor cells to vascular repair after percutaneous coronary intervention:a randomized controlled trial.Lancet,2016,388:S34-S34.
28 Hamasaki S C,Tei C W.Effect of coronary endothelial function on outcomes in patients undergoing percutaneous coronary intervention.Journal of Cardiology,2011,57(3):231-238.
29杨丽峰,吕吉元,贾永平.经皮冠状动脉介入治疗对急性冠状动脉综合征患者内皮功能的影响.中国动脉硬化杂志,2005,13(4):93-94.
30顼志兵,汪卫东,张莉芬,等.冠心病中医证型与血浆vWF,Ps,hsCRP,FIB,TXB2,6-keto-PG1α关系的临床研究.中国中医基础医学杂志,2015,21(1):66-68.
31 Yan Bgi Bwa M,Kurihar H,Kimura S,et al.A novelpotent Vasoconstrictor peptide produced by vascular endothelial cells.Nature,1988,332:411-415.
32张琼,宋旭东,陈爱华,唐晓明.颈、股动脉内-中膜厚度及血管内皮舒张功能与冠心病的相关性.实用医学杂志,2009,25(7):1066-1068.
33邓远琼,张志娟,李宏翔,等.血管内皮功能及同型半胱氨酸对冠心病的预测价值研究.中国全科医学,2013,16(31):3672-3675.
34王静,吴时达.中药对血管内皮功能的保护作用.中国动脉硬化杂志,2005,13(1):116-118.
35周惠芬,何昱,张宇燕,等.丹红有效成分配伍对缺氧损伤脑微血管内皮细胞的保护作用.中国中药杂志,2014,39(22):4399-4404.
36王淑君,王万铁,熊建华,等.红花注射液对脑缺血再灌注损伤家兔血浆TXA2/PGI2水平的影响.中国现代应用药学,2003,20(2):100-102.